U.S. patent application number 17/599059 was filed with the patent office on 2022-06-09 for conformable dressing.
The applicant listed for this patent is 3M INNOVATIVE PROPERTIES COMPANY. Invention is credited to Steven B. Heinecke, Kristopher E. Hunter, Krystal J. Scheibel.
Application Number | 20220175585 17/599059 |
Document ID | / |
Family ID | |
Filed Date | 2022-06-09 |
United States Patent
Application |
20220175585 |
Kind Code |
A1 |
Scheibel; Krystal J. ; et
al. |
June 9, 2022 |
CONFORMABLE DRESSING
Abstract
When thin-film dressings are used to secure a device, the
dressing might need to stretch in some areas to accommodate varying
sizes of a device, while remaining stiffer in some areas to limit
stretching of the materials. Excessive stretching of the materials
can cause the dressing to peel away from the skin or cause the
underlying device to not be sufficiently secured. The disclosed
dressing can be used to secure a device and includes perforations
near the device securement area to allow for isolated regions of
adjustability to accommodate a secure fit between the dressing and
device.
Inventors: |
Scheibel; Krystal J.;
(Minneapolis, MN) ; Hunter; Kristopher E.;
(Woodbury, MN) ; Heinecke; Steven B.; (New
Richmond, WI) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
3M INNOVATIVE PROPERTIES COMPANY |
St. Paul |
MN |
US |
|
|
Appl. No.: |
17/599059 |
Filed: |
March 19, 2020 |
PCT Filed: |
March 19, 2020 |
PCT NO: |
PCT/IB2020/052552 |
371 Date: |
September 28, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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62827400 |
Apr 1, 2019 |
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International
Class: |
A61F 13/02 20060101
A61F013/02 |
Claims
1. A dressing comprising: a first major surface, second major
surface, opposite the first major surface, defined by a perimeter
around a body layer, wherein the second major surface comprises an
adhesive; a slot, wherein the slot is an extension of the perimeter
within the body layer to a terminal end and wherein the slot is
separated by a first and second portion of the body layer; and a
first perforation set extending at least partially through a
thickness of the body layer and extending from the perimeter at the
slot to within the body layer.
2. The dressing of claim 1, wherein the body layer comprises one or
more layers.
3. The dressing of claim 1, wherein the body layer further
comprises a support material.
4. The dressing of claim 1, wherein the support material covers a
portion of the body layer.
5. The dressing of claim 1, wherein the support material extends to
the perimeter.
6. The dressing of claim 1, wherein the support material is less
elastic than the body layer.
7. The dressing of claim 1, wherein the first perforation set
extends through the support material.
8. The dressing of claim 1, wherein the slot forms a gap separating
the first and second portion of the body layer.
9. The dressing of claim 1, wherein the slot extends along a
dressing slot axis.
10. The dressing of claim 1, wherein the first and second body
portions are symmetrical about the dressing slot axis.
11. The dressing of claim 1, wherein the first perforation set
extends entirely through the thickness of the body layer.
12. The dressing of claim 1, wherein the first perforation set is
at the terminal end of the slot.
13. The dressing of claim 1, wherein the first perforation set is
at the terminal end of the slot and parallel to the dressing slot
axis.
14. The dressing of claim 1, further comprising a second
perforation set extending at least partially through the body
layer.
15. The dressing of claim 1, wherein the second perforation set
extends from the perimeter to within the body layer.
16. The dressing of claim 1, wherein the first perforation set has
a first end and a second end, and the second perforation set has a
first end and a second end.
17. The dressing of claim 1, wherein the first end of the first
perforation set is the same as the first end of the second
perforation set.
18. The dressing of claim 1, wherein the first end of the first
perforation set is different from the first end of the second
perforation set.
19-26. (canceled)
27. A system for securing a device comprising: the medical dressing
of claim 1; the device overlying a substrate; wherein the medical
device overlies the device and secures to the substrate and wherein
the device aligns with the slot.
28. A method of securing a device to a substrate comprising:
applying the medical dressing of claim 1 to the device and the
substrate; wherein the device aligns with the slot.
29-30. (canceled)
Description
TECHNICAL FIELD
[0001] The present disclosure relates to a conformable dressing
comprising a backing layer with a perforation set for enabling
controlled elasticity.
BACKGROUND
[0002] Transparent film dressings are widely used on skin because
they protect the skin by acting as a barrier to contaminating
liquids and bacteria. For example, transparent film dressings are
available under a number of trade names such as TEGADERM.TM. (3M
Company, St. Paul, Minn.).
[0003] The polymeric films used in those dressings and drapes are
conformable, i.e., the films are extremely thin, flexible and
supple. They are typically supplied with a releasable protective
liner covering the adhesive coated surface of the film. To prevent
the adhesive coated film from wrinkling during application, various
delivery systems have been proposed to address this problem, such
as those disclosed in U.S. Pat. No. 6,685,682.
[0004] Thin polymeric films that are flexible and resilient are
beneficial when used on skin that flexes, stretches, and retracts.
However, for some applications, the high flexibility and resiliency
of the thin polymeric film can move and stretch too much causing
the film to peel or release from the skin. Therefore, medical
dressings have been developed that include stiffer, less
conformable material secured to the thin polymeric film. For
example, U.S. Pat. No. 5,088,483 discloses an adhesive composite
that includes a conformable backing and a permanent adhesive
reinforcement around the periphery of the adhesive composite. One
example of a commercially available medical dressing with a
reinforcement layer is TEGADERM.TM. IV Advanced Dressing (3M
Company, St. Paul Minn.).
SUMMARY
[0005] When thin-film dressings are used to secure a device, the
dressing might need to stretch in some areas to accommodate varying
sizes of a device, while remaining stiffer in some areas to limit
stretching of the materials. Excessive stretching of the materials
can cause the dressing to peel away from the skin or cause the
underlying device to not be sufficiently secured. The disclosed
dressing can be used to secure a device and includes perforations
near the device securement area to allow for isolated regions of
adjustability to accommodate a secure fit between the dressing and
device.
[0006] In one embodiment, the dressing comprises a first major
surface; second major surface, opposite the first major surface,
defined by a perimeter around a body layer, wherein the second
major surface comprises an adhesive; and a slot for receiving a
device. The slot is an extension of the perimeter within the body
layer to a terminal end. The slot is separated by a first and
second portion of the body layer. In one embodiment, the dressing
further comprises a first perforation set that extends at least
partially through the thickness of the flexible backing layer and
extending from the perimeter of the dressing at the slot to within
the body layer.
[0007] In one embodiment, the body layer further comprises a
support material secured to the body layer. In one embodiment, the
support material covers a portion of the body layer. In one
embodiment, the support material extends to the perimeter. In one
embodiment, the support material is less elastic than the body
layer.
[0008] In one embodiment, the first perforation set extends through
the thickness of the support material. In one embodiment, the slot
extends along a dressing slot axis. In one embodiment, the first
and second body portions are symmetrical about the dressing slot
axis. In one embodiment, the first perforation set is at the
terminal end of the slot. In one embodiment, the first perforation
set is at the terminal end of the slot and parallel to the dressing
slot axis.
[0009] In one embodiment, the dressing further comprises a second
perforation set through the body layer. In one embodiment, the
second perforation set extends from the perimeter to within the
body layer. In one embodiment, the first perforation set has a
first end and a second end, and the second perforation set has a
first end and a second end. In one embodiment, the first end of the
first perforation set is the same as the first end of the second
perforation set. In one embodiment, the first end of the first
perforation set is different from the first end of the second
perforation set. In one embodiment, the first perforation set is
substantially perpendicular to the dressing slot axis. In one
embodiment, the second perforation set is substantially
perpendicular to the dressing slot axis. In one embodiment, the
first perforation set extends from the first end at the perimeter
through the body layer to the perimeter. In one embodiment, the
first perforation set extends from the first end at the perimeter
through the body layer to a different portion of the perimeter. In
one embodiment, the first perforation set is at the terminal end of
the slot, parallel with the dressing slot axis, and extends through
the body layer to a different portion of the perimeter.
[0010] In one embodiment, a method of securing a device comprises
applying the dressing to a device, wherein the device aligns with
the slot. In one embodiment, the method further comprises
separating at least a portion of the first perforation set adjacent
to the device. In one embodiment, the method further comprises
applying a tape strip across the slot, underlying the device.
BRIEF DESCRIPTION OF DRAWINGS
[0011] FIG. 1 is a first embodiment of a dressing comprising a
first perforation set and second perforation set;
[0012] FIG. 2 is a side sectional view of FIG. 1 through line
2-2;
[0013] FIG. 3 is the dressing of FIG. 1 with an underlying device
at the slot and tape strip across the slot underlying the
device;
[0014] FIG. 4 is another embodiment of a dressing comprising a
first perforation set;
[0015] FIG. 5 is another embodiment of a dressing, specifically a
tape, comprising a single perforation set;
[0016] FIG. 6 is another embodiment of a dressing, specifically a
tape, comprising a first perforation set and a second perforation
set;
[0017] FIG. 7 is another embodiment of a dressing comprising a
first perforation set.
[0018] While the above-identified drawings and figures set forth
embodiments of the invention, other embodiments are also
contemplated, as noted in the discussion. In all cases, this
disclosure presents the invention by way of representation and not
limitation. It should be understood that numerous other
modifications and embodiments can be devised by those skilled in
the art, which fall within the scope and spirit of this invention.
The figures may not be drawn to scale.
DETAILED DESCRIPTION
[0019] The disclosed dressing comprises a body layer with a slot
for receiving a device. From the perimeter at the slot is at least
one perforation set that allows for flexible expansion of the slot
to accommodate various sizes of devices, such as tubing.
[0020] FIG. 1 is a first embodiment of a dressing 100 comprising a
first perforation set 150 and a second perforation set 155, FIG. 2
is a side sectional view of the dressing 100 shown in FIG. 1, and
FIG. 3 is the dressing 100 shown with an underlying device 190 and
an extending tube 195.
[0021] The dressing 100 has a first major surface 110 and second
major surface 120, which is opposite the first major surface 110.
At least a portion of the second major surface 120 comprises an
adhesive 160 (see FIG. 2) for securing the dressing 100 to an
underlying substrate, such as skin.
[0022] A perimeter 130 surrounds the dressing 100 and defines a
body layer 140 of the dressing 100. The body layer 140 is typically
a thin, flexible material that can be applied over an irregular,
contoured substrate 165, such as skin. The body layer 140 can be a
single or multilayer construction and can further comprise an
additional support material 170 secured to at least a portion of
the body layer 140. Various types of suitable materials for the
body layer 140 and support material 170, if included, are described
below.
[0023] The dressing 100 has a slot 145, which is an extension of
the perimeter 130 within a portion of the body layer 140. The slot
145 is separated by a first portion 146 of the body layer 140 and a
second portion 148 of the body layer 140. The slot 145 has a width
forming a gap between the first portion 146 and the second portion
148 of the body layer 140. The slot 145 has a receiving end 142
that is open and is a separation between the first portion 146 and
second portion 148 of the body layer 140, and the slot 145 has a
terminal end 144 that is the innermost extension of the slot 145
into the body layer 140. In one embodiment, the slot 145 is linear
along a slot axis 143. However, the slot 145 can be of various
sizes, shapes, width or lengths so long as it provides a separation
between the first portion 145 and second portion 148 of the body
layer 140. In this embodiment, the first portion 146 and second
portion 148 of the body layer 140 are symmetric about the slot axis
143. In use, the device 190, and tubing 195, will extend through
the slot 145.
[0024] A first perforation set 150 is at the perimeter 130 at the
slot 145. The first perforation set 150 is a set of through cuts
with each cut separated from another cut by the body layer 140. The
cuts of the first perforation set 150 extend at least partially
through the thickness of the body layer 140 to create an area of
structural weakness of the body layer 140. In some embodiments, the
through cuts of the first perforation set 150 extend entirely
through the body layer 140. In some embodiment, the through cuts
extend partially into the body layer 140. If the body layer 140 is
a multilayer construction, the through cuts could extend entirely
through one layer, and not through other layers of the body layer
140. In one embodiment, such as shown in FIG. 1, the cut of the
first perforation set 150 is a slit with essentially no width,
meaning no material was removed from the body layer 140 during
cutting. In one embodiment, the cut of the first perforation set
150 has a width of material removed.
[0025] It is understood the individual cuts of a perforation set
may be the same length as one another or may be of varying lengths.
For example, the length of each cut may graduate from shorter to
longer or from longer to shorter. The same with the spacing between
each individual cut. may be the same length as one another or may
be of varying lengths. For example, the spacing between each
individual cut may graduate from shorter to longer or from longer
to shorter.
[0026] Laterally, the first perforation set 150 extends from a
first end 152 at the perimeter 130 at the slot 145 to a second end
154. In this embodiment, the second end 154 is within the body
layer 140. The first perforation set 150 can be in a line, an
array, or cluster. If the first perforation set 150 is in a line,
it can be a straight, angled, or curved line.
[0027] The first perforation set 150 can be positioned at or near
the terminal end 144 of the slot 145 as shown in FIGS. 1 and 3. The
first perforation set 150 can extend at least partially from the
perimeter 130 into the body 140 at any angle relative to the
dressing slot axis 143. In the embodiment depicted in FIG. 1, the
first perforation set 150 extends substantially perpendicular to
dressing slot axis 143 into body 140.
[0028] The dressing 100 can have more than one perforation set. Any
additional perforation sets can have features such as described for
the first perforation set. As shown in the embodiment in FIG. 1-3,
there is a first perforation set 150 and a second perforation set
155 at the slot 145. The second perforation set 155 is a set of
through cuts with each cut separated from another cut by the body
layer 140. Similar to the first perforation set, the second
perforation set 155 extends at least partially through the
thickness of the body layer 140.
[0029] Laterally, the second perforation set 155 extends from a
first end 156 at the perimeter 130 at the slot 145 to a second end
158. In this embodiment, the second end 158 is within the body
layer 140. The second perforation set 155 can be in a line, and
array, or cluster. If the second perforation set 155 is in a line,
it can be a straight, angled, or curved line. In the embodiment
depicted in FIG. 1, the second perforation set 155 extend
substantially perpendicular to dressing slot axis 143 into body
140, opposite from the first perforation set 150. In this
embodiment, the second perforation set 155 is substantially the
same size and shape as the first perforation set 150. It is
understood that first and second perforation sets can be different
sizes, lengths, shapes from one another. The second perforation set
155 provides an area of weakness in the structural strength of the
body layer 140 of the dressing 100 and will cause a break at the
second perforation set 155 to expand the side of the slot 145 for a
larger tube 195.
[0030] In one embodiment, the first perforation set 150, and second
perforation set 155, if included, have cut lengths between 0.025
inches and 1.0 inches wide. In one embodiment, the body layer 140
between cuts is between 0.01 inches and 0.05 inches wide.
[0031] In use, the dressing 100 is applied over a device 190, like
shown in FIG. 3, with a portion of the device 190, such as tubing
195 extending through the slot 145. The tubing 195 size can vary.
Therefore, the first perforation set 150 provides an area of
weakness in the structural strength of the body layer 140 of the
dressing 100 and will cause a break at the first perforation set
150 to expand the side of the slot 145 fora larger tube 195.
[0032] Including both a first perforation set 150 and a second
perforation set 155, increases the ability to expand the width of
the slot 145 to accommodate the device 190 or tubing 195. In one
embodiment, the dressing 100 is for placement over an intravenous
catheter device 190 with tubing 195. The intravenous device 190 is
placed under the body layer 140 of the dressing 100, and the tubing
195 extends through the slot 145. For a large size tubing 195, at
least a portion of the first perforation set 150 and/or second
perforation set 155 will expand the width of slit 145 to size of
the tubing 195.
[0033] Optionally, the body layer 140 of the dressing 100 can
include a support material 170. The support material 170 secures
with at least a portion of the body layer 140. In some embodiments
the body layer 140 is very flexible and elastic. The support
material 170 can be provided in regions to limit the flexibility
and elasticity of the body layer. The support material 170 can be
provided to have a flexibility or elasticity in one direction that
is different than the flexibility or elasticity in a second
direction. This can further help control the overall extensibility
and flexibility of the overall dressing.
[0034] When included, the support material 170 is secured to the
body layer 140, through adhesive, thermal bonding, lamination, or
other commonly used securement techniques. The support material 170
provides structural strength to the dressing 100, and therefore,
independently, is less elastic than the body layer 140. In one
embodiment, the support material 170, independently, has
essentially no elasticity, such that is may be unable to stretch
and/or it may be unable to recover from a stretch. In one
embodiment, the support material 170, may be more elastic in one
direction (machine direction) than in the cross direction
(transverse direction), but overall it has less elasticity than the
body layer 140.
[0035] Elasticity can be measured by any number of commonly used
means for evaluating stretch and recovery of a material. In one
embodiment, the body layer 140 (independent of the support
material) has an elongation at break of at least 200%. In one
embodiment, the body layer 140 (independent of the support
material) has an elongation at break of at least 1000%. In one
embodiment, the body layer 140 (independent of the support
material) has an elongation at break of less than 500%. In one
embodiment, the support material 170 (independent of the backing
layer) has an elongation at break of at least 20%. In one
embodiment, the support material 170 (independent of the backing
layer) has an elongation at break of at least 100%. In one
embodiment, the support material 170 has an elongation at break
less than 200%.
[0036] In the embodiment shown in FIGS. 1-3, a support material 170
extends adjacent the entire perimeter 130 of the dressing 100, but
is not continuous across the entire body 140. The support material
170 is not located in the central window 142 of the dressing 100 to
allow for a transparent window to view the underlying substrate 165
or device 190. In this embodiment, the support material 170
comprises polymeric film(s), nonwoven fibrous webs, woven fibrous
webs, knits, films and other backing materials, which maybe
translucent or transparent. The arrangement of the body layer 140
and support material 170 is similar to a 3M Tegaderm IV Advanced
Securement Dressing, which includes a nonwoven layer adjacent to a
thin polyurethane film. When the support material 170 is included,
the perforation sets might be included in only those portion
including the support material. Typically, the stiffness or
rigidity of the support material will limit the propagation of the
perforation opening.
[0037] The body layer 140 can be thin, flexible, elastic and a
sufficiently impermeable barrier to the passage of liquids and at
least some gases, which protects the covered site from external
contaminants. Being elastic allows for the body layer 140 to
expand, contract, stretch and recover as the underlying substrate,
such as skin, moves. The support material 170 can be included in
specific areas, like the perimeter 130, to limit flexibility and
stretching of the body layer 140. Excessive stretching of the body
layer 140 can cause peeling or a loose fit to the underlying
device. When a support material 170 is included in the dressing
100, expansion at the slot 145 can be significantly restricted.
Therefore, the perforation sets 150, 155 provide for isolated
stretching and expansion in the areas with limited ability to
stretch due to the support material 170. If a support material 170
is included, the perforation set 150 remains within the areas of
the support material 170 to prevent further propagation of the
tear.
[0038] FIG. 4 is a second embodiment of a dressing 102. Dressing
102 is substantially similar to the embodiment of the dressing 100
depicted in FIG. 1, and so the same reference numbers are used to
identify the same structural elements. However, dressing 102 has
only the first perforation set 150 and does not include a second
perforation set. Also, the first perforation set 150 extends
parallel to dressing slot axis 143 from the apex of the terminal
end 144 of slot 145. The first perforation set 150 extends from a
first end 152 at the perimeter 130 to a second end 154 within the
body layer 140. This arrangement of perforation set 150 allows for
selectively tearing along the perforation set 150 to accommodate a
catheter of varying sizes and shapes. If a support material 170 is
included, the perforation set 150 remains within the areas of the
support material 170 to prevent further propagation of the
tear.
[0039] FIG. 5 is a third embodiment of a dressing 103. In this
embodiment, the dressing 103 is a tape strip. The same reference
numbers are used to identify the same structural elements as
described in FIGS. 1-3. This dressing 103 comprises a first
perforation set 150. In this embodiment, the first perforation set
150 extends from a first end 152 adjacent the perimeter 130 at the
apex of the terminal end 144 of slot 145 at least partially through
the body layer 140 to a second end 154 also on the perimeter 130
along a line substantially parallel to dressing slot axis 143. Slot
145 is positioned in the body 140 such that the portions of the
body on either side of slot 145 are symmetric about dressing slot
axis 143. Support material is not included. It is understood that
the support material could be included over a portion or over the
entire dressing. This arrangement of first perforation set 150
allows for selectively tearing along the dressing slot axis for
improved coverage of the site around a catheter and for tearing the
tape completely to aid in removal of the tape. This dressing 103
can be used in combination with a dressing such as shown in FIG. 1
or FIG. 3 to further secure the device 190, like shown in FIG.
3.
[0040] FIG. 6 is a fourth embodiment of a dressing 104. In this
embodiment, the dressing 104 is a tape strip. The same reference
numbers are used to identify the same structural elements as
described in FIGS. 1-3. This dressing 104 comprising a first
perforation sets 150 and second perforation set 155. In this
embodiment, the first perforation sets 150 extend from a first end
152 adjacent the perimeter 130 proximate to the apex of the
terminal end 144 of slot 145 to a second end 154 into the body
layer 140 along a line substantially perpendicular to dressing slot
axis 143. The second perforation sets 155 extend from a first end
156 adjacent the perimeter 130 proximate to the apex of the
terminal end 144 of slot 145 to a second end 158 into the body
layer 140 along a line substantially perpendicular to dressing slot
axis 143. In this embodiment, the first perforation sets 150 and
second perforation set 155 are additionally symmetrical about slot
145 and the dressing slot axis 143. Support material is not
included. It is understood that the support material could be
included over a portion or over the entire dressing. This
arrangement of first perforation sets 150 and second perforation
set 155 allows for selectively tearing along the dressing slot axis
for improved coverage of the site around a catheter and
accommodation of catheters of varying sizes and shapes. This
dressing 104 can be used in combination with a dressing such as
shown in FIG. 1 or FIG. 3 to further secure the device 190, like
shown in FIG. 3.
[0041] FIG. 7 is an embodiment of a dressing 105. Dressing 105 is
substantially similar to the embodiment of the dressing 100
depicted in FIG. 1 and dressing 102 depicted in FIG. 4, and so the
same reference numbers are used to identify the same structural
elements. However, dressing 105 has a first perforation set 150
that extends perpendicular to dressing slot axis 143 from a side of
the slot 145. The first perforation set 150 extends from a first
end 152 at the perimeter 130 to a second end 154 within the body
layer 140. This first perforation set 150 has a portion that
extends in a first direction and a second portion that extends in a
second direction. This arrangement of first perforation set 150
form an arrow ".rarw." shape. This arrangement of perforation set
150 allows for selectively tearing along the perforation set 150 to
accommodate a catheter of varying sizes and shapes.
[0042] The dressing disclosed may be made by conventional
techniques (e.g., extrusion, solvent casting, calendaring,
laminating, adhesive coating, and the like) which are familiar to
those skilled in the art. U.S. Pat. No. 6,685,682, the disclosure
of which is herein incorporated by reference, discloses
constructions and methods for making dressings with backing layers
and support material. It will be understood that the perforation
sets can be applied using know cutting or perforation techniques to
the body layer prior to final construction of the dressing or after
final construction of the dressing.
[0043] Body Layer
[0044] The dressings are useful to provide an impermeable barrier
to the passage of liquids and at least some gases. The dressings
are well suited for medical application and for securing to skin.
Representative barriers for use as the body layer may include
non-woven and woven fibrous webs, knits, films, foams, polymeric
films. In some embodiments, a transparent substrate is desirable to
allow for viewing of the underlying skin or device.
[0045] In one embodiment, the body layer has high moisture vapor
permeability, but generally impermeable to liquid water so that
microbes and other contaminants are sealed out from the area under
the substrate. One example of a suitable material is a high
moisture vapor permeable film such as described in U.S. Pat. Nos.
3,645,835 and 4,595,001, the disclosures of which are herein
incorporated by reference. In high moisture vapor permeable
film/adhesive composites, the composite should transmit moisture
vapor at a rate equal to or greater than human skin such as, for
example, at a rate of at least 300 g/m.sup.2/24 hrs at 37.degree.
C./100-10% RH, or at least 700 g/m.sup.2/24 hrs at 37.degree.
C./100-10% RH, or at least 2000 g/m.sup.2/24 hrs at 37.degree.
C./100-10% RH using the inverted cup method as described in U.S.
Pat. No. 4,595,001. Pattern coated adhesives may be used to
increase the moisture vapor transmission. In one embodiment, the
body layer is an elastomeric polyurethane, polyester, or polyether
block amide films. These films combine the desirable properties of
resiliency, elasticity, high moisture vapor permeability, and
transparency. A description of this characteristic of body layers
can be found in issued U.S. Pat. Nos. 5,088,483 and 5,160,315, the
disclosures of which are hereby incorporated by reference
[0046] Commercially available examples of potentially suitable body
layers may include the thin polymeric film backings sold under the
trade names TEGADERM (3M Company), OPSITE (Smith & Nephew),
etc.
[0047] In some embodiment, it may be desirable that the body layer
is relatively thin to improve conformability. For example, the
backing layer may be formed of polymeric films with a thickness of
200 micrometers or less, or 100 micrometers or less, potentially 50
micrometers or less, or even 25 micrometers or less.
[0048] Support Material
[0049] The support material provides strength to the thin, flexible
body layer. The support material therefore has more stiffness and
less elasticity than the body layer. The support material may be a
coating, such as an adhesive, or may be a self-supporting substrate
such as another film, woven, knitted, or nonwoven fabric. For
example, U.S. Pat. No. 5,088,483 discloses a permanent adhesive as
a reinforcement that could be used as the support material.
[0050] In one embodiment, a woven, knitted, or nonwoven fabric used
as the support material. One example of nonwoven for the support
material is a high strength nonwoven fabric available from E. I.
Dupont de Nemours & Company of Wilmington, Del. under the
trademark Sontara. Other suitable nonwoven webs include a
hydroentangled polyester fabric available from Veratec, a division
of International Paper of Walpole, Mass. Another suitable nonwoven
web is the nonwoven elastomeric web described in U.S. Pat. No.
5,230,701, herein incorporated by reference.
[0051] Adhesive
[0052] Any number of adhesives can be used with the dressing.
Suitable adhesives are pressure sensitive and in certain
embodiments have a relatively high moisture vapor transmission rate
to allow for moisture evaporation. Suitable pressure sensitive
adhesives include those based on acrylates, urethane, hydrogels,
hydrocolloids, block copolymers, silicones, rubber-based adhesives
(including natural rubber, polyisoprene, polyisobutylene, butyl
rubber etc.) as well as combinations of these adhesives. The
adhesive component may contain tackifiers, plasticizers, rheology
modifiers as well as active components including for example an
antimicrobial agent.
[0053] The pressure sensitive adhesives that may be used in the
dressings may include adhesives that are typically applied to the
skin such as the acrylate copolymers described in U.S. Pat. No. RE
24,906, particularly a 97:3 isooctyl acrylate:acrylamide copolymer.
Another example may include a 70:15:15 isooctyl acrylate:
ethyleneoxide acrylate:acrylic acid terpolymer, as described in
U.S. Pat. No. 4,737,410. Other potentially useful adhesives are
described in U.S. Pat. Nos. 3,389,827; 4,112,213; 4,310,509; and
4,323,557. Inclusion of medicaments or antimicrobial agents in the
adhesive is also contemplated, as described in U.S. Pat. Nos.
4,310,509 and 4,323,557.
[0054] Silicone adhesive can also be used. Generally, silicone
adhesives can provide suitable adhesion to skin while gently
removing from skin. Suitable silicone adhesives are disclosed in
PCT Publications WO2010/056541 and WO2010/056543, the disclosure of
which are herein incorporate by reference.
[0055] The pressure sensitive adhesives may, in some embodiments,
transmit moisture vapor at a rate greater to or equal to that of
human skin. While such a characteristic can be achieved through the
selection of an appropriate adhesive, it is also contemplated that
other methods of achieving a high relative rate of moisture vapor
transmission may be used, such as pattern coating the adhesive on
the backing, as described in U.S. Pat. No. 4,595,001. Other
potentially suitable pressure sensitive adhesives may include
blown-micro-fiber (BMF) adhesives such as, for example, those
described in U.S. Pat. No. 6,994,904.
[0056] Different portions of the dressing may include different
adhesives, such as disclosed in U.S. Patent Application Publication
2015/014949 titled "Medical Dressing with Multiple Adhesives." For
example, a portion may include an acrylate adhesive while another
portion may include a silicone adhesive. In one embodiment, to
prevent edge separation, adjacent the perimeter is acrylate
adhesive, while near the central portion there is silicone
adhesive. In one embodiment, to strongly secure with a device or
tubing near the central portion there is acrylate adhesive, while
near the perimeter in contact with skin is silicone adhesive.
[0057] Optional Components
[0058] In some applications, an absorbent material may also be used
in conjunction with the dressings described herein. An absorbent
material can be any of a variety of materials including, but not
limited to, foam, sponge, super absorbent fibers/particles,
hydrocolloid compositions, knitted, woven or nonwoven fabrics. The
absorbent material can absorb body fluid underlying the
dressing.
[0059] An optional release liner may be included that covers all or
a portion of the adhesives to prevent contamination of the
adhesives prior to use. In one embodiment, the package that
contains the dressing may serve as a release liner. Suitable
release liners can be made of Kraft papers, polyethylene,
polypropylene, polyester or composites of any of these materials.
In one embodiment, the liners are coated with release agents such
as silicones.
[0060] An optional carrier may be included that covers all or a
portion of the first major surface of the body layer, providing
structural support if the dressing is thin and highly flexible. The
carrier may be removable from the first major surface once the
dressing is placed on skin. The carrier can be constructed of a
variety of materials such as fabric that are woven or kitted,
nonwoven material, papers, or film. In one embodiment, the carrier
is along the perimeter of the first major surface of the dressing
and is removable from the first major surface, similar to the
carrier used in the 3M Tegaderm.TM. Transparent Film Dressing,
available from 3M Company, St. Paul, Minn.
[0061] An optional antimicrobial component may be included that is
either separate from the adhesive dressing or may be integral with
the dressing. The antimicrobial component is placed near or
adjacent to the insertion site of the device 190 to inhibit
microbial growth in and around the insertion site. The
antimicrobial component can be absorbent foam or gel, such as used
in a 3M Tegaderm.TM. CHG I. V. Securement Dressing, available from
3M Company.
[0062] Although specific embodiments have been shown and described
herein, it is understood that these embodiments are merely
illustrative of the many possible specific arrangements that can be
devised in application of the principles of the invention. Numerous
and varied other arrangements can be devised in accordance with
these principles by those of skill in the art without departing
from the spirit and scope of the invention. The scope of the
present invention should not be limited to the structures described
in this application, but only by the structures described by the
language of the claims and the equivalents of those structures.
* * * * *